FDA-Device2014-06-25Class II
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Spacelabs Healthcare Inc
Hazard
Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.
Sold states
Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US.
Affected count
46 units distributed within the US; 108 units distributed outside the US.
Manufactured in
35301 SE Center St, N/A, Snoqualmie, WA, United States
Products
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1824-2014Don't want to check this manually?
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